Raltegravir (By mouth)

Introduction

Raltegravir (ral-TEG-ra-vir)

Treats human immunodeficiency virus (HIV) infection. HIV causes acquired immune deficiency syndrome (AIDS). Raltegravir does not cure HIV or AIDS. It is used with other medicines to slow the progress of the disease.

Brand Name(s)

Isentress

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet, Chewable Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Raltegravir is used with other medicines to treat HIV infection. Make sure you take all of your medicines as your doctor has prescribed.
• You may chew or swallow the chewable tablets whole. The film-coated tablets must be swallowed whole.
• Do not replace the chewable tablets with the film-coated tablets. Ask your doctor or pharmacist if you have any questions.
• Do not change or stop using this medicine without checking with your doctor first. Do not allow yourself to run out of this medicine. Contact your doctor or pharmacist when your supply is running low.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you also use rifampin (Rifadin®, Rimactane®).

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or if you have severe liver disease or other types of infection.
• You should not breast feed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
• Tell your doctor if you have phenylketonuria (PKU). The chewable tablet contains phenylalanine, which can make this condition worse.
• Serious allergic reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have a blistering, peeling, or severe skin rash; fever or chills; muscle or joint pain; swelling of the face, lips, tongue, or throat; unusual tiredness; or yellowing of the eyes or skin. This could be life-threatening and requires immediate medical attention.
• Your immune system may get stronger when you start taking HIV medicine. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis.
• This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.Blood tests may be needed to check for side effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or severe skin rash
• Dark-colored urine or pale stools
• Fever, chills, cough, sore throat, or muscle or joint pain
• Nausea, vomiting, loss of appetite, or pain in your upper stomach
• Painful cold sores or blisters on the lips, nose, eyes, or genitals
• Redness, pain, or swelling of your eye, eyelid, or inner lining of the eyelid
• Swelling of your face, lips, or mouth
• Trouble breathing
• Unusual tiredness or weakness
• Yellowing of your skin or the whites of your eyes

If you notice these less serious side effects, talk with your doctor:

• Mild skin rash

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088